The Hypertension in the Very Elderly Trial (HYVET)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00122811
• Date of registration: 13/07/2005
• Prospective Registration: No
• Primary sponsor: Imperial College London
• Public title: The Hypertension in the Very Elderly Trial (HYVET)
• Scientific title: The Hypertension in the Very Elderly Trial (HYVET)
• Date of first enrolment: November 2000
• Target sample size: 4000
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00122811
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Bulgaria, China, Finland, Romania, Russian Federation, United Kingdom

Contacts

• Name: Christopher J Bulpitt, MD, FRCP
• Affiliation: Imperial College London

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 80 or older

- Sitting systolic BP 160-199 mmHg AND sitting diastolic BP < 110 mmHg

Exclusion Criteria:

- Known accelerated hypertension (retinal haemorrhages or exudates or papilloedema).

- Overt clinical congestive heart failure requiring treatment with a diuretic or
angiotensin converting enzyme inhibitor. Subjects allowed if treated with digoxin
only.

- Renal failure (serum creatinine of more than 150 µmol/l).

- Previous documented cerebral or subarachnoid haemorrhage in the last 6 months.
(Ischaemic cerebral and cardiac events do not exclude, although the patient must be
neurologically and cardiologically stable.)

- Condition expected to severely limit survival, e.g. terminal illness.

- Known secondary hypertension (e.g. renal artery stenosis, chronic renal
insufficiency, and endocrine cause).

- Gout.

- Clinical diagnosis of dementia.

- Resident in a nursing home, i.e. where the dependency and care requirements of the
patients are such that they require the regular input of qualified nurses and
therefore the majority of staff in the home are nurses (other forms of residential
care are acceptable).

- Unable to stand up or walk

- Participation in a drug trial within the past month preceding selection.

- Alcohol or drug abuse.

- Less than 2 months placebo run-in.

- Contraindications to use of trial drugs



Age minimum: 80 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Indapamide SR 1.5mg; Perindopril 2-4mg

Primary Outcome(s)

All strokes (fatal and non-fatal) [Time Frame: Duration of trial]

Secondary Outcome(s)

Total mortality [Time Frame: duration of trial]

Fracture rates [Time Frame: Duration of trial]

Stroke mortality [Time Frame: Duration of Trial]

Cardiac mortality [Time Frame: Duration of trial]

Cardiovascular mortality [Time Frame: Duration of trial]

Secondary ID(s)

RG/97010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

British Heart Foundation

Institut de Recherches Internationales Servier